MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINAL CORD NERVE STIMULATOR

Model Number FR8A-SPR-B0

Device Problem Output Problem (3005)

Patient Problem Electric Shock (2554)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

For the report of loss of therapy: the perm - loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device in an off-label location and no attempts to reprogram the waa were ruled out as potential causes of the reported issue.Other potential causes of loss of therapy/no therapy are stimulator placement too close to the nerve, improper stimulation parameters, stimulator damage during/before implant procedure, patient co-morbidities, and patient expectations.Migration was ruled out via x-ray.For the report of shock: the clinical representative reported the patient stated experiencing an occasional shocking sensation due to the programmed amplitude being set too high.The clinical representative reduced the amplitude and the patient is receiving minimal relief, but is no longer experiencing the shocking sensation.Potential causes of shock/unintended stimulation include stimulation parameter settings, stimulator placement too close to the nerve, mri induced stimulation, implanting the stimulator too close to the nerve, stimulator electrical failure and interference from other electro magnetic sources.The waas were not returned as they appear to be functioning as expected and the rep will continue with standard reprogramming to establish therapy.The stimulator is used to treat pain.The cause of loss of therapy is unknown.However, the cause of the overstimulation/shocking sensation is likely due to incorrectly programmed waa stimulation parameters (user error - clinical representative).

Event Description

On (b)(6) 2021, the patient reported a loss of therapy.The stimwave clinical representative attempted reprogramming the waa to re-establish pain relief.When the clinical representative increased the amplitude of the programming parameters, the patient reported feeling a shocking sensation.The shocking sensation experienced by the patient was reported by the clinical representative to stimwave quality on (b)(6) 2022.The patient is currently receiving minimal relief.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 13514298
• MDR Text Key: 289602565
• Report Number: 3010676138-2022-00019
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: 010081822502064817230501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO210530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: WAA (PDBT-915-2K), SN: (B)(4); WAA (PDBT-915-2K), SN: (B)(4)
• Patient Outcome(s): Required Intervention